One of the study's main conclusions is that the special nature of pharmaceuticals and the pharmaceutical market means that it is essential for the State to play a special role by establishing regulatory policies. These are to counter market weaknesses relating to unbalanced information and lack of power of decision-making with respect to health rights and drug access.

2.1. GENERAL REGULATIONS

The case studies show that a key element in any health system - and perhaps the main one - is a limited list of drugs which the system will reimburse. For economic and therapeutic reasons, an insurance system cannot guarantee reimbursement of the full range of pharmaceutical products on the market in a given country. It is interesting to note from the studies that the lists of reimbursable drugs contained, on average, 600 items, compared with several thousand products on the markets of most of these countries.

Several general types of regulation need to be put in place on: the availability and form of product information; standard treatment guidelines; and standardised training of prescribers.

But the starting point for all these measures must be the use of a limited list, drawn up in accordance with the needs, disease profile, and the economic and human resource potential of each country.

2.1.1. RESTRICTED LISTS

One of the starting points is on the regulation of the number and types of drugs to be managed by the social security system. Restrictive lists must be drawn up, both positive and negative, that will act as a prescription guide within the different health insurance systems. This list regulates the institutional demand for drugs, and drug selection must be based on clearly established criteria of quality, efficacy, cost and therapeutic priority. The lists includes cost-effective products and eliminates the least cost-effective.

2.1.2. USE OF THE INTERNATIONAL NONPROPRIETARY NAME

The identification of drugs of guaranteed quality, proven therapeutic equivalency by their generic International Nonproprietary Name, makes for a more transparent and efficient market. Competing products are more visible and consumers have greater choice of equivalent products, according to their economic means. The generic name in the same or larger size print as the brand name must be put on all drug packaging. In addition doctors should be made to prescribe by generic name only.

Promoting generic drugs, identified by their INN and of demonstrated bioequivalence with the innovator product they may replace, can help realize health sector reform objectives by improving drug availability, reducing costs, increasing competition and by rationalising not only drug selection but also use.

2.1.3. PREPARATION AND DISSEMINATION OF STANDARD TREATMENT GUIDELINES

Public regulatory policies should encourage the use of standard treatment and prescribing guidelines, drawn up on the basis of the highest scientific criteria. Such protocols define [i] the optimal combination, in terms of cost-effectiveness and utility cost of resources and materials, including drugs, for treating a specific illness, and [ii] the optimal dosage and treatment period. Guidelines ensure that disease and patient management take into account a social dimension, proven efficacy and cost-effectiveness.

2.1.4. PACKAGING REQUIREMENTS IN ACCORDANCE WITH THE DOSAGE NECESSARY FOR STANDARD TREATMENTS

Experience in the US with dispensing using packaging in line with the prescribed medical dosage has proved its usefulness in avoiding waste by over-purchasing. It results in savings for patients and the system, each buying only what they need. This procedure should become standard practice in health insurance systems.

2.1.5. PROFESSIONAL TRAINING AND DEVELOPMENT

In social security systems, it is health professionals - especially doctors - who set the demand for drugs. In prescribing, they define appropriate combinations of treatment, drug use, and the dosage and treatment period. New training methods and continuing education can encourage correct professional development, counter over-prescribing and encourage objective evaluation of the influence exercised by pharmaceutical companies in prescribing drugs. A key goal of professional training must be to change the focus from curative to preventive medicine.

2.1.6. SUBSTITUTION OPTIONS

Establishing lists of drugs which can be substituted (interchangeable), approved by the regulatory authority, in pharmacies gives consumers a choice between biologically equivalent products at lower prices. These are known as lists of interchangeable products and regulatory authorities prepare them on the basis of previously established criteria.

2.1.7. PRICE LISTS

Publication of price lists allows the public to be guided as to the cheaper, bioequivalent drugs, increasing their choice, which strengthens consumer demand as a method of price regulation.